Search / Trial NCT06236789

Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer

Launched by YONSEI UNIVERSITY · Jan 24, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Castration Resistant Prostate Cancer Ifosfamide/Mesna Efficacy Safety

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of a treatment called ifosfamide, combined with mesna, for men who have advanced prostate cancer that no longer responds to hormone therapy. Prostate cancer is a common cancer in men, and while there are standard treatments available, some patients may not see improvement and are in need of new options. This study aims to gather more information on how well ifosfamide works for these patients, especially for those who have already been treated with another medication called docetaxel.

To participate in this trial, men must be at least 19 years old and have a confirmed diagnosis of prostate cancer that is resistant to hormone treatments. They should also have had previous treatment with docetaxel and be in relatively good health (measured by a scale called ECOG). Those with other recent cancers or certain health issues will not be eligible. Participants in the study will receive the ifosfamide/mesna treatment and will be closely monitored for how well the treatment works and any side effects they may experience. This is an important step in finding new options for patients with challenging cases of prostate cancer.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. 19 years and older adult male
  • 2. Patients with histologically confirmed prostate cancer
  • 3. Castration-resistant prostate cancer
  • 4. ECOG 2 or less
  • 5. Patients with previous docetaxel exposure
  • 6. Patients with available PSA level
  • 7. Patients with evaluable disease based on RECIST 1.1
  • Exclusion Criteria:
  • 1. Patients with other primary cancers diagnosed within 3 years other than prostate cancer
  • 2. Patients with a history of organ transplantation
  • 3. Hormone sensitive prostate cancer
  • 4. ECOG 3 or higher
  • 5. Patients without previous docetaxel exposure
  • 6. Patients previously exposed to ifosfamide
  • 7. Patients without available PSA level
  • 8. Patients without evaluable disease based on RECIST 1.1

Trial Officials

Sang Joon Shin

Principal Investigator

Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine

About Yonsei University

Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.

Locations

Seoul, , Korea, Republic Of

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0